Safety and Feasibility Study of Umbilical Cord Blood Mononuclear Cells Transplant to Treat Ischemic Stroke
Phase 1 Clinical Trial to Establish the Safety and Feasibility of Transplants of Umbilical Cord Blood Mononuclear Cells in Chronic Ischemic Stroke
調査の概要
詳細な説明
This is an open-label, delayed-treatment trial.
A total of 12 subjects fulfill the inclusion and exclusion criteria will be recruited and randomly assigned into two treatment group. Group A (early-treatment group) will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0. Group B (delayed-treatment group) will participate in 6 months observation before the UCBMC transplantation at Month 6. All subjects will be followed up for 18 months from enrollment at Day 0. Long-term follow-up will be carried up to 36 months if applicable.
The adverse events and safety parameters will be collected and recorded. In addition, the stroke scores , gait and brain MRI will be obtained before and after the treatment to assess the safety and potential treatment effect of UCBMC in chronic ischemic stroke.
研究の種類
入学 (予想される)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
-
Hong Kong、香港
- 募集
- Queen Mary Hospital
-
コンタクト：
- Karrie Kiang
- 電話番号：+852 2255 4468
- メール：mykiang@hku.hk
-
主任研究者：
- Gilberto Ka Kit Leung, MD
-
Shatin、香港
- 募集
- Prince of Wales Hospital
-
コンタクト：
- Waisang Poon, MD
- 電話番号：+852 2632 1625
- メール：stroke-study@surgery.cuhk.edu.hk
-
主任研究者：
- Waisang Poon, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- either gender, age 35 -65 years old;
- ischemic stroke > 6 months and < 60 months;
- stable hemiplegia or hemiparesis condition > 3 months;
- stroke-induced clinical deficits affecting motor, perceptual, or language functions, with NIHSS of 5-15;
- stroke in the middle cerebral artery territory;
- subjects able to understand, sign and date the informed consent form
Exclusion Criteria:
- non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage;
- pregnant or lactating women;
- alcohol or drug abuse in previous 3 months;
- significant medical diseases or infections;
- current participation in another investigational study or taking any investigational drug within last 4 weeks before the screening;
- unavailability of HLA-matched umbilical cord blood unit;
- investigator suggests that the subject would not suitable to perform the surgery or participate in the study
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Group A - UCBMC Early Treatment Group
Group A subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0.
|
Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
|
|
実験的：Group B - UCBMC Delayed Treatment Group
Group B subject will partipate in 6 months observation and then receive the UCBMC transplant at month 6.
|
Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
National Institutes of Health Stroke Scale
時間枠：18 months, up to 36 months
|
The change from the baseline in National Institutes of Health Stroke Scales
|
18 months, up to 36 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
European Stroke Scale (ESS)
時間枠：18 months, up to 36 months if applicable
|
The change from baseline in ESS
|
18 months, up to 36 months if applicable
|
|
Barthel Index
時間枠：18 months
|
18 months
|
|
|
Min-Mental State Examination (MMSE)
時間枠：18 months
|
The change from baseline in MMSE
|
18 months
|
|
MRI
時間枠：18 months
|
The change in MRI between pre-treatment and post-treatment
|
18 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Safety as assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations.
時間枠：18 months, up to 36 months follow-up
|
Safety are assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations.
|
18 months, up to 36 months follow-up
|
協力者と研究者
協力者
捜査官
- 主任研究者：Waisang Poon, MD、The Chinese University of Hong Kong, Prince of Wales Hospital
- 主任研究者：Gilberto Ka Kit Leung, MD、The University of Hong Kong, Queen Mary Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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